Tyra Biosciences, Inc. (Nasdaq: TYRA) is a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in FGFR biology. The Company's in-house precision medicine platform, SNÅP, enables the rapid and precise refinement of structural drug design through iterative molecular SNÅPshots that help predict genetic alterations most likely to cause acquired resistance to existing therapies. TYRA's initial focus is on applying its accelerated small molecule drug discovery engine to develop therapies in targeted oncology and genetically defined conditions. TYRA is based in Carlsbad, CA.

Position Overview:

The AD, Product Development & Technical Operations will support cross-functional efforts in formulation, process development, tech transfer, as well as ensuring a robust supply chain for our clinical trials and future commercial needs. This role will work closely with internal team members as well as with external partners.

Responsibilities include, but are not limited to:

Drug-Product and Process Development:

• Contribute to the design, phase-appropriate formulation and process strategies for our solid oral dosage forms.
• Review development protocols, master batch records, and control strategies, ensuring these are aligned and up to date.

Tech Transfer and Scale-Up:

• Ensure our processes from the lab bench to pilot scale are robust and in compliance with the most recent regulations, and scale them up for commercial production.
• Leverage knowledge of Quality by Design (QbD) and Design of Experiments (DoE) to ensure these transitions are smooth.

Clinical and Commercial Supply:

• Ensure clinical trials and future commercial launches are stocked.
• Support and coordinate aspects of supply chain, procurement, and production scheduling to guarantee uninterrupted GMP supply for Phase I-III trials and crucial launch stock.

Regulatory and Quality:

• Contribute to the CMC sections of our regulatory filings (IND/IMPDs, NDAs/MAAs) by compiling data and drafting relevant sections.
• Work closely with Quality to help investigate deviations, support and manage CAPA implementation, and assist with preparing for inspections and resolving inspection findings.

• Facilitate effective and open communications with all stakeholders.
• Support other various CMC-related initiatives as needed.

Position Requirements & Experience:

• BS or MS in Pharmaceutics, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• 10-12 years of relevant experience in pharma/biotech product development, preferably with some exposure to solid oral dosage forms. Experience supporting at least one molecule through early clinical development is a plus.
• Extensive experience with solid oral dosage forms (think tablets, mini-tablets, capsules) and pediatric formulations.
• Hands-on experience with DoE software principles and statistical process controls; experience with software like JMP or Minitab is a bonus.
• Strong understanding of cGMP, FDA, EMA, and ICH guidelines.
• Experience and exposure to different formulation techniques or novel delivery systems preferred (ie: mini-tablets or ODTs).
• Understanding of how CDMOs operate is a requirement. Experience in selecting CDMOs, managing contracts, and coordinating activities with CDMOs required.
• Experience contributing to regulatory documents or supporting agency queries and inspections. Experience writing or co-authoring CMC modules preferred.
• Strong understanding of drug development, and the strategic and operational requirements from pre-IND through NDA to commercial launch. Experience in NDA/BLA or EU MAA launches preferred.
• Experience with cross-functional team roles and responsibilities in pharmaceutical development, with a track record of influencing and problem solving to find creative solutions to technical issues that arise.
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
• Proven ability to manage competing priorities in a fast-paced, rapid-growth environment.
• Ability to work independently and collaboratively adapt as part of a team.
• Strong interpersonal skills, including verbal and written communication.
• Candidates must be authorized to work in the U.S.
• Travel may be required up to 30%.

Pay Range and Benefits:

Base Salary Range: $185,679 - $212,920 USD

Individual compensation will be determined based on factors such as work location, skills, education, training, and experience.

What we offer US-based Employees:

· Competitive base, bonus, new hire and ongoing equity packages

· The starting compensation range(s) for this role is for a full-time employee (FTE) basis

· Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment

· Employer -paid Medical, dental, and vision insurance

· Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage

· 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions

· Employee Stock Purchase Plan

· 14 -18 paid holidays, including office closure between December 25th and January 1st

· Flexible vacation

· Sick time

· Fitness Program

· Get Outdoors Program

· Paid parental leave benefit

· Tuition assistance

Job Type: Full-Time

Work authorization: United States (Required) Work Location: Remote flexibility with periodic in-person collaboration

Equal Opportunity Employer: Tyra Biosciences, Inc. is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.

Notice to Recruiters and Third-Party Agencies: The Talent Acquisition team manages the recruitment and employment process for Tyra. To protect the interests of all parties involved, Tyra will only accept resumes from a recruiter once a fully-executed search agreement is in place. Agencies are hereby specifically directed not to contact Tyra employees directly in an attempt to present candidates. Tyra will consider any candidate for whom an Agency and/or Recruiter has submitted an unsolicited resume to have been referred, free of any charges or fees.